(147 days)
The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.
This document is a 510(k) premarket notification for a medical device, specifically the Ranfac Aspirating Needle with Adjustable Guide. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a clinical study with acceptance criteria for device performance in a diagnostic accuracy context.
Therefore, many of the requested details about acceptance criteria for device performance, a specific study proving it, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of submission. This document highlights the device's physical and material characteristics, its intended use, and its adherence to relevant manufacturing and sterilization standards.
Here's the breakdown of what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided in this document. This submission focuses on demonstrating substantial equivalence through comparison of materials, design, technological characteristics, and adherence to standards, not on clinical performance metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance
Not applicable. No diagnostic accuracy test set is described. The "test" here refers to non-clinical testing against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for diagnostic accuracy is established as this is not a diagnostic device with performance claims.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor is it a diagnostic imaging device typically associated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (an aspiration needle), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context relates to meeting engineering and biocompatibility standards.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Information that can be extracted related to the device and its "acceptance":
While there isn't a table of clinical acceptance criteria and performance as you'd find for a diagnostic algorithm, the document does describe criteria for the device's design, materials, and manufacturing, and states that these criteria are met. This is implicitly the "acceptance criteria" for this type of device and submission.
"Acceptance Criteria" and "Study Proving Acceptance" (as interpreted from the document for a physical device):
| Acceptance Criteria (Standards Adherence) | Reported Device Performance (Claimed Conformance) |
|---|---|
| Material Composition: Stainless steel needle tubing for medical devices. | Conforms to ISO 9626 First edition 1991-09-01, Amendment 1 2001-06-01 (Stainless steel needle tubing for the manufacture of medical devices. FDA Standards Recognition Number 6-163). |
| Luer Lock Connection: Conical fittings with a 6% (Luer) taper - General requirements. | Conforms to ISO 594/1 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. FDA Standards Recognition Number 6-11). |
| Luer Lock Connection: Conical fittings with a 6% (Luer) taper - Lock fittings. | Conforms to ISO 594-2 Second edition 1998-09-01 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. FDA Standards Recognition Number 6-129). |
| Sterilization Process: Requirements for development, validation and routine control of a sterilization process. | Conforms to ISO 11135-1 (Sterilization of health care products -Ethylene Oxide - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices. FDA Recognition Number 14-331). |
| Sterilization Residuals: Biological evaluation of medical devices - Ethylene oxide sterilization residuals. | Conforms to ISO 10993-7 (Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals. FDA Recognition Number 14-278). |
| Biological Indicators: Guidance for selection, use and interpretation of results for sterilization. | Conforms to AAMI/ANSI/ISO 14161:2009 (Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results. FDA Recognition Number 14-285). |
| Packaging: Requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices. | Conforms to ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA Recognition Number 14-355). |
| Intended Use & Technological Characteristics: Similarities to predicate devices. | The Ranfac Aspiration Needle with Adjustable Guide is similar in materials and design to the predicate devices (K131157, K121181), comprising stainless steel cannula and stylets with plastic handles and luer fittings for standard piston syringes. Its intended use (aspiration of bone marrow or autologous blood) is also consistent. |
Study that proves the device meets the acceptance criteria:
The document states that the "Non-clinical Data: Standards" section indicates compliance. The "study" isn't a single traditional clinical trial but rather the demonstration of adherence to specified international and national standards relevant to medical device manufacturing, materials, and sterilization. This involves testing and validation performed by the manufacturer to ensure the device meets the requirements of these standards. The conclusion explicitly states: "Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Aspiration Needle with Adjustable Guide, subject of this premarket notification and the predicate devices, the Ranfac Aspiration Needle with Adjustable Guide has been shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." This "showing" is the proof for this type of submission.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.